AmblyopiaNCT02767856
Regimens of Intermittent Occlusion Therapy for Amblyopia in Children
A study testing IO-therapy Glasses in people with Amblyopia, run by Salus University at 1 site in United States.
Trial summary
This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks? Children aged 3- to 8-years with untreated… Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- IO-therapy Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 30 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The following criteria must be met for the patient to be enrolled in the study:
- Age 3 to < 8 years
- Unilateral amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- Criteria for strabismus: At least one of the following criteria must be met:
- Heterotropia at distance and/or near fixation on examination (with or without spectacles)
- History of strabismus surgery
Show all 38Show fewer
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- Criteria for anisometropia: At least one of the following criteria must be met:
- >0.50 D difference between eyes in spherical equivalent
- >0.50 D difference between eyes in astigmatism in any meridian
- Amblyopic eye has no myopia (> -0.25 D spherical equivalent).
- Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
- Visual acuity in the sound eye 20/32 or better
- Inter-eye acuity difference ≥ 2 logMAR lines (i.e., amblyopic eye acuity at least 2 lines worse than sound eye acuity)
- No previous amblyopia treatment within 6 months.
- Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
- Requirements for spectacle correction:
- For patients meeting criteria for only strabismus
- Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion.
- For patients meeting criteria for anisometropia or combined-mechanism
- Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
- Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes
- Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
- Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
- Spectacles meeting above criteria must be worn either:
- for 4 weeks immediately prior to enrollment, or
- until visual acuity in amblyopic eye is stable (defined as two consecutive visual acuity measurements at least 4 weeks apart with no improvement of one line or more)
- An acuity measurement done any of the following ways may be considered the first of two consecutive measurements:
- in current glasses,
- in trial frames with full correction of hypermetropia with cycloplegia, or
- in new glasses.
- Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
- Ocular examination within 6 months prior to enrollment.
- Gestational age > 34 weeks and birth weight > 1500 grams
- Parent willing to accept randomization
- Parent willing to be contacted and has access to phone
- Parent does not anticipate relocation outside area within study period.
Who cannot join
- Amblyopic eye has myopia worse than -3.00 D spherical equivalent.
- Prior intraocular or refractive surgery
- Ocular pathologies that impact vision
- Cognitive impairment that prohibits accurate data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intense vs Standard Regimens of Intermittent Occlusion Therapy for Unilateral Moderate Amblyopia in Children
This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?
Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.
- Conditions
- Amblyopia
- Being tested
- IO-therapy Glasses
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IO-therapy GlassesDevice
| Study group | Role | What they receive |
|---|---|---|
| Intense 12-hour IO-therapy Group | Experimental | Participants wear 12-hour daily IO-therapy glasses for 4 weeks Receives: Device: IO-therapy Glasses |
| Standard 4-hour IO-therapy Group | Active comparator | Participants wear 4-hour daily IO-therapy glasses for 12 weeks Receives: Device: IO-therapy Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Improvement
visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
Measured: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Secondary outcomes (3)
Stereoacuity Test
Stereoacuity in arcsec was converted to log scale. so log10(stereo) will be reported.
The higher value indicates a poorer binocular visual function.
Measured: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Objective Total Treatment Hours
Objective total treatment hours at the primary outcome visit measured with a microsensor
Measured: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Objective Adherence
objective adherence measured with a microsensor to the treatment regimen
Measured: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startSep 2016
- Primary completion30 May 2021
- Study completion30 May 2021
Why it stopped: PI changed the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767856
- Sponsor's protocol ID
- HJW1604
- Status last verified
- May 2022
- First submitted
- 8 May 2016
- Last updated
- 25 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wang J, Malik A, Jin J, Pang Y, Yin K, Allen M, Grigorian A, Scombordi B, Bailey J, Aljohani S, Funari K, Shoge R, Meiyeppen S, Myung J, Soni A, Neely DE. Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):361. doi: 10.1186/s13063-020-04284-4.
PubMed 32345348
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense vs Standard Regimens of Intermittent Occlusion Therapy for Unilateral Moderate Amblyopia in Children
- ClinicalTrials.gov ID
- NCT02767856
- Acronym / sponsor ID
- HJW1604
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed the institution.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Posted 14 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to answer the question: What if the Intermittent Occlusion (IO-therapy) glasses were prescribed all day (12-hours) in which the total time of treatment only took 4 weeks instead of the current treatment time (4 hours) in which it takes 12 weeks?
Children aged 3- to 8-years with untreated moderate unilateral amblyopia will be enrolled and randomized into 2 groups: 1) Intense 12-hour IO-therapy Group for 4 weeks treatment; or 2) Standard 4-hour IO-therapy glasses Group for 12 weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intense 12-hour IO-therapy Group | Experimental | Device: IO-therapy GlassesParticipants wear 12-hour daily IO-therapy glasses for 4 weeks |
| Standard 4-hour IO-therapy Group | Active comparator | Device: IO-therapy GlassesParticipants wear 4-hour daily IO-therapy glasses for 12 weeks |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (38 listed)
- Age 3 to < 8 years
- Unilateral amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- Amblyopic eye has no myopia (> -0.25 D spherical equivalent).
- Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
- No previous amblyopia treatment within 6 months.
Key exclusion criteria (4 listed)
- Amblyopic eye has myopia worse than -3.00 D spherical equivalent.
- Prior intraocular or refractive surgery
- Ocular pathologies that impact vision
- Cognitive impairment that prohibits accurate data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IO-therapy Glasses | Device | Intense 12-hour IO-therapy Group, Standard 4-hour IO-therapy Group |
Primary outcome
Visual Acuity Improvement
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
visual acuity difference between the primary outcome measure and baseline in the amblyopic eye; visual acuity was measured with ATS- HOTV method
3 secondary outcomes
Stereoacuity Test
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Objective Total Treatment Hours
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Objective Adherence
Time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32345348Wang J, Malik A, Jin J, Pang Y, Yin K, Allen M, Grigorian A, Scombordi B, Bailey J, Aljohani S, Funari K, Shoge R, Meiyeppen S, Myung J, Soni A, Neely DE. Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):361. doi: 10.1186/s13063-020-04284-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IO-therapy Glasses in people with Amblyopia, run by Salus University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity Improvement (time frame: 4 weeks for the Intense Group and 12 weeks for the Standard Group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02767856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.